Study to Examine Multiple Doses of TMC647055 in Combination With Telaprevir
A Phase I, Open Label Trial in Genotype 1 HCV-Infected Subjects to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Repeated Doses of TMC647055 Given in Combination With Telaprevir
3 other identifiers
interventional
7
1 country
2
Brief Summary
The purpose of this study is to assess safety, tolerability, pharmacokinetics (how the drug is absorbed into the bloodstream) and antiviral activity of repeated doses of TMC647055 given in combination with telaprevir in HCV infected patients. TMC647055 is being investigated for the treatment of hepatitis C infection. Telaprevir has recently been approved in the USA and in Europe for the treatment of chronic hepatitis C infected patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 19, 2012
CompletedFirst Posted
Study publicly available on registry
April 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedFebruary 17, 2014
February 1, 2014
1.6 years
April 19, 2012
February 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Plasma PK parameters for TMC647055 and TVR after combination therapy in panel 1 and 2.
9 samples at specific timepoints on days 1, 6 and 10 in panel 1, on days 1, 6 and 14 in panel 2 and daily on all other days in the 2 panels.
Number of participants with adverse events as a measure of safety and tolerability.
Continuously from screening until the last trial related visit.
Change from baseline values for clinical laboratory tests.
at screening, panel 1 on day 1, 6, 10 and 11, panel 2 on day 1, 6, 14 and 15, the 2 follow-up visits in case of drop-out from the panels, extension phase at every visit except the last follow-up visit
Change from baseline values for ECG and vital signs.
At screening, daily in panel 1 and 2 (Vital signs only in panel 1 day 1, 6, 11, in panel 2 day 1, 6, 15), at follow-up visits in case of drop-our from the panels, in extension phase at week 4, 12, 16 (ECG only), 24, 36, 48 and first follow-up visit
Change from baseline for physical examination.
at screening, panel 1 on day 1, 6 and 11, panel 2 on day 1, 6 and 15, extension phase at the week 4, 12, 24, 36, 48 and first follow-up visit
Individual evalution of HCV RNA levels.
For the 2 panels: 3 samples on day 1, 2 samples on day 2 and further daily samples except day 7 & 9 in panel 1 and day 7, 9, 11 & 13 in panel 2.
Study Arms (2)
Panel 1
EXPERIMENTALTMC647055 in combination with TVR for 10 days. Immediately followed by the extension phase: TVR at a dose of 750 mg every 8 hours for 12 weeks in combination with Peg IFN and RBV followed by either 12 or 36 weeks of PegIFN -RBV treatment alone.
Panel 2
EXPERIMENTALTMC647055 in combination with TVR for 10 or 14 days. Immediately followed by the extension phase: TVR at a dose of 750 mg every 8 hours for 12 weeks in combination with Peg IFN and RBV followed by either 12 or 36 weeks of PegIFN -RBV treatment alone.
Interventions
type=exact number, unit=mg, number=500, form=solution, route=oral use. Panel 1: TMC647055 is to be taken twice daily at a dose of 500 mg per day for 10 days.
type=exact number, unit= mg, number=1125, form=tablet, route=oral use. TVR is to be taken twice daily at a dose of 1125 mg for 10 days.
type= exact number, unit= mcg, number=180, form=solution, route=subcutaneous. PegIFN is to be injected once per week for 24 or 48 weeks.
type=exact number, unit=mg, number=1000 or 1200, form=tablet, route=oral use. RBV is to be taken at 1000 or 1200 mg per day in 2 divided doses, depending on the weight for 24 or 48 weeks.
Eligibility Criteria
You may qualify if:
- genotype 1a or 1b HCV infection with HCV RNA level \> 100,000 IU/mL
- A documented prior relapser patient to previous treatment regimens or treatment-naïve
- Patient must have documentation of a liver biopsy within 3 years before the screening visit or must agree to have a fibroscan/elastography examination within the screening period
- Patient is judged to be medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening
You may not qualify if:
- Evidence of liver cirrhosis
- Evidence of decompensated liver disease
- Evidence of any other cause of significant liver disease in addition to hepatitis C
- receiving or having received any treatment for HCV during the 6 months before screening
- History or evidence of current abuse of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator's opinion would compromise subject's safety and/or compliance with the study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Berlin, Germany
Unknown Facility
München, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen R&D Ireland Clinical Trial
Janssen R&D Ireland
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2012
First Posted
April 20, 2012
Study Start
April 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
February 17, 2014
Record last verified: 2014-02